Dilapan-S Osmotic Dilator in Pre-induction of Labor

Uterine Cervical Incompetence Clinical Trial

Official title:

Prospective Collection of Data About the Use of the Dilapan-S Osmotic Dilator in Pre-induction of Labor in Women With/Without Caesarean Section in Their History

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098382
• Other study ID #: DIS2013-002
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: July 28, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2014
• Source: Medicem International CR s.r.o.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Description:

Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Single pregnancy

• Pregnancy more than 36 weeks

• Vertex presentation of the fetus

• Cervix Score less than 4 points

Exclusion Criteria:

• Contraindication to vaginal delivery

• Pathological fetal station

• States after uterine body surgery - except for Caesarean section

• Clinical signs of uterine, vaginal or vulvar infection

• Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Uterine Cervical Incompetence

Intervention

Device:
• Dilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction

Locations

Country	Name	City	State
Czech Republic	Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Medicem International CR s.r.o.

Country where clinical trial is conducted

Czech Republic, 

References & Publications (13)

Allen RH, Goldberg AB; Board of Society of Family Planning. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception. 2007 Aug;76(2):139-56. Epub 2007 Jul 10. — View Citation

Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889. — View Citation

Borgatta L, Lopatinsky I, Shaw FM. Overcoming unsatisfactory colposcopy. Use of osmotic dilators. J Reprod Med. 1997 May;42(5):271-5. — View Citation

Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6. — View Citation

Chambers DG, Willcourt RJ, Laver AR, Baird JK, Herbert WY. Comparison of Dilapan-S and laminaria for cervical priming before surgical pregnancy termination at 17-22 weeks' gestation. Int J Womens Health. 2011;3:347-52. doi: 10.2147/IJWH.S25551. Epub 2011 Oct 20. — View Citation

Chen FC, Bergann A, Krosse J, Merholz A, David M. Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan-S for cervical ripening before first trimester curettage. Eur J Obstet Gynecol Reprod Biol. 2008 Jun;138(2):176-9. Epub 2007 Nov 5. — View Citation

Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11. — View Citation

Lyus R, Lohr PA, Taylor J, Morroni C. Outcomes with same-day cervical preparation with Dilapan-S osmotic dilators and vaginal misoprostol before dilatation and evacuation at 18 to 21+6 weeks' gestation. Contraception. 2013 Jan;87(1):71-5. doi: 10.1016/j.contraception.2012.07.006. Epub 2012 Aug 13. — View Citation

Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-8. doi: 10.1097/AOG.0000000000000080. — View Citation

Roztocil A, Pilka L, Jelínek J, Koudelka M, Miklica J. A comparison of three preinduction cervical priming methods: prostaglandin E2 gel, Dilapan S rods and Estradiol gel. Ceska Gynekol. 1998 Feb;63(1):3-9. — View Citation

Samuel MI, Parsons JH. Hygroscopic dilator (Dilapan-S) and misoprostol combination for the early first-trimester termination of pregnancy: a pilot study. J Fam Plann Reprod Health Care. 2009 Jan;35(1):45-7. doi: 10.1783/147118909787072234. — View Citation

Serhal P, Ranieri DM, Khadum I, Wakim RA. Cervical dilatation with hygroscopic rods prior to ovarian stimulation facilitates embryo transfer. Hum Reprod. 2003 Dec;18(12):2618-20. — View Citation

Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Course of removal of Dilapan-S rods after pre-induction	The evaluation of the course of removal of Dilapan-S after termination of preinduction by physician as very easy, easy, standard, with some complications or very complicated.	At the moment of removal of Dilapan-S rods after labor pre-induction phase up to 1 day after delivery	Yes
Other	Occurance of complication of rupture of fetal sac due to the use of Dilapan-S or other complications related to the use of Dilapan-S		From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase	Yes
Other	Patients´evaluation of pre-induction of labor with Dilapan-S	Subjective satisfaction Pain experienced during Dilapan-S insertion and pre-induction phase Quality of relax and sleep Frequency and intensity of uterine contractions during pre-induction	From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase	Yes
Primary	Cervix (Bishop) score	To evaluate, based on the value obtained in the Cervix Score, the efficacy of use of the Dilapan-S device in the indication labor pre-induction, and to compare outcomes in patients with/without a history of Caesarean section.	Before pre-induction of labor performance and up to 24 h after pre-induction of labor	No
Secondary	Total duration of pre-induction	To compare these outcomes in patients with and without a history of Caesarean section.	From Dilapan-S rods insertion up to 24 hours	No
Secondary	Number of dilators inserted	Expected the insertion from 2 to 5 Dilapan-S rods. To compare these results in patients with/without Cesarean section in their medical history.	At the moment of Dilapan-S insertion up to 24 hours until their removal	No
Secondary	Uterine contractions	To compare these results in patients with/without Caesearean section in their medical history. Uterine hypertonus is diagnosed, when the number of uterine contractions is higher than 5 within 10 minutes (during pre-induction).	From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase	Yes
Secondary	The course of delivery (vaginally or Caesarean section)	To compare the rate of vaginal delivery/Caesarean sections in patients with/without Caesarean section in their medical history.	From active phase of labor up to 1 day after delivery	Yes
Secondary	Apgar score	To compare these results in patients with/without Caesarean section in their medical history.	At 1st, 5th and 10th minute after delivery	Yes
Secondary	pH of the fetus	To compare the results in patients with/without caesarean section in their medical history. The rate of ceses with pH below 7,1.	Up to 10 minutes after delivery	Yes
Secondary	Infection complications of mother / fetus	Clinical signs of infection are defined as follows: CRP levels > 8 mg/l; Leukocyte count > 18 x 109/l; Body temperature > 37.5°C	Up to 5 days from the birth	Yes